Non-invasive blood component analyzer

• US 6,064,898 A
• Filed: 09/21/1998
• Issued: 05/16/2000
• Est. Priority Date: 09/21/1998
• Status: Expired due to Term

• Current Assignee: Essential Medical Devices
• Original Assignee: Essential Medical Devices
• Inventors: Aldrich, Thomas K
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US09/157,453
• Time in Patent Office: 603 Days
• Field of Search: 600/310, 600/315, 600/316, 600/319, 600/322, 600/323, 600/326, 600/328, 600/330, 600/335, 600/336, 600/407, 600/473, 600/476
• US Class Current: 600/316
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters

Abstract

A non-invasive blood component analyzer using spectrophotometry, with systole/diastole corrections for tissue absorbance, and with built-in monitoring of light path length to allow its accurate use in subjects with widely varying finger size and/or varying pulse amplitude. Blood components that are able to be analyzed include oxy-hemoglobin, total hemoglobin, bilirubin, glucose, hormone levels and a variety of drugs.

Claims

1. A non-invasive method for measuring the concentration of a blood component in a subject'"'"'s blood, said method comprising the steps of:

(a) providing at least one light source for directing light of at least one wavelength through a tissue of the subject in which light absorbance of arterial blood can be detected by measuring changes in absorbance during pulsatile flow of blood,

(b) providing at least one detector for detecting the portion of the light not absorbed by the tissue of the subject;

(c) measuring the absorbance of the light at the wavelength by the tissue at both the systolic and diastolic phase of the pulsatile flow;

(d) determining the physical dimension of said tissue at both the systolic and diastolic phase of the pulsatile flow;

(e) calculating a ratio of the change in light absorbance between the systolic and diastolic phase divided by the change in the physical dimension of said tissue between the systolic and diastolic phase;

(f) determining the concentration of the blood component by comparing the ratio calculated in step (e) to a reference.

2. The method of claim 1, wherein the light source emits light at a wavelength wherein the blood component absorbs strongly relative to all other substances expected to be present in the subject'"'"'s blood.

3. The method of claim 1, wherein the blood component is hemoglobin and the wavelength of light is approximately 548 nm.

4. The method of claim 1, wherein the blood component is hemoglobin and the wavelength of light is approximately 506 nm.

5. The method of claim 1, wherein the blood component is hemoglobin and the wavelength of light is approximately 521 nm.

6. The method of claim 1, wherein the blood component is hemoglobin and the wavelength of light is approximately 569 nm.

7. The method of claim 1, wherein the blood component is hemoglobin and the wavelength of light is approximately 586 nm.

8. The method of claim 1 wherein the light source is a light-emitting diode, a laser, a heater coil, or an incandescent lamp.

9. The method of claim 1 wherein the detector is a photodetector.

10. The method of claim 1, which the physical dimension of said tissue is the linear distance between the light source and the detector.

11. The method of claim 10 wherein the linear distance between the light source and the detector is measured using a linear displacement transducer, a pair of opposing piezoelectric crystals or a magnetometer.

12. The method of claim 1 wherein the reference is the ratio of the change in light absorbance between the systolic and diastolic phase divided by the change in physical dimension between the systolic and diastolic phase for subjects with known concentrations of the blood component.

13. A non-invasive method for measuring the concentration of a blood component in a subject'"'"'s blood, said method comprising the steps of:

(a) choosing a first wavelength of light at which the blood component absorbs light relatively strongly and all other substances expected to be present in the subject'"'"'s blood absorb light to a lesser degree;

(b) choosing a second wavelength of light to be used as a reference wavelength, said reference wavelength absorbed at a relatively low level by both the blood component of inte(rest and all other substances expected to be present in the subject'"'"'s blood;

(c) providing a first light source for directing light at the first wavelength through a tissue of the subject in which light absorbance of arterial blood can be detected by measuring changes in absorbance during pulsatile flow of blood;

(d) providing a second light source for directing light at the reference wavelength through the tissue of the subject, the second light source either being the first light source adapted to emit light at more than one wavelength or a separate light source located adjacent to the first light source;

(e) providing at least one detector for detecting the portion of the light of the first wavelength and the light of the reference wavelength not absorbed by the tissue of the subject;

(f) determining a physical dimension of the tissue at both the systolic and diastolic phases of the subject'"'"'s pulsatile flow;

(g) calculating the change in the physical dimension of said tissue between the systolic and diastolic phases of the subject'"'"'s pulsatile flow;

(h) measuring the absorbance of light at the first wavelength and the reference wavelength at the systolic and diastolic phases of pulsatile blood flow;

(i) calculating the change in light absorbance between the systolic and diastolic phases for both the first wavelength and reference wavelength;

(j) calculating the difference between the changes in absorbances at each of the two wavelengths calculated in step (i);

(k) calculating a value by applying a formula dividing the difference between the changes in absorbances at the two wavelengths as calculated in step (i) by the change in the physical dimension of said tissue between the systolic and diastolic phases as calculated in step (g);

(l) determining the concentration of the blood component by comparing the value calculated n step (k) to a reference.

14. The method of claim 13 wherein step (k) comprises calculating the value by applying an empirically derived regression equation employing two variables, the first variable being the ratio of the difference between the changes in absorbances at the two wavelengths as calculated in step (j) to the change in the physical dimension of said tissue between the systolic and diastolic phases as calculated in step (g) and the second variable being the reciprocal of the change in the physical dimension of said tissue between the systolic and diastolic phases as calculated in step (g).

15. The method of claim 13 wherein said blood component is glucose.

16. The method of claim 15 wherein said first wavelength is approximately 9600 nm.

17. The method of claim 15 wherein said reference wavelength is approximately 8400 nm.

18. The method of claim 13 wherein at least one of said light sources is a heater coil.

19. The method of claim 18 wherein said first and second light sources are the same heater coil and band pass filters are interposed between the heater coil and the tissue.

20. The method of claim 13 wherein at least one of said light sources is a light-emitting diode, laser or incandescent lamp.

21. The method of claim 13 wherein the physical dimension of said tissue is the linear distance between the light sources and the detector.

22. The non-invasive method of claim 21 wherein the linear distance between the light sources and the detector is measured using a linear displacement transducer, a pair of opposing piezoelectric crystals or a magnetometer.

23. The method of claim 13 wherein the reference is a value calculated in accordance with step (k) for reference subjects with known concentrations of the blood component.

24. A non-invasive method for measuring the concentration of a blood component in a subject'"'"'s blood by light absorbance when an interfering substance absorbs at the optimal wavelength for detecting the concentration of the blood component, said method comprising:

(a) choosing three wavelengths of light, a first wavelength at which both the blood components and the interfering substance absorb relatively strongly in comparison to all other substances expected to be present in the subject'"'"'s blood, a second wavelength at which the blood component and the interfering substance absorb differentially, and a third wavelength at which the blood component and the interfering substance absorb at approximately the same low level;

(b) providing a first light source for directing light at the first wavelength through a tissue of the subject in which light absorbance of arterial blood can be detected by measuring changes in absorbance during pulsatile flow of blood;

(c) providing a second light source for directing light at the second wavelength through said tissue of the subject, the second light source either being the first light source adapted to emit light at more than one wavelength or a separate light source located adjacent the first light source,

(d) providing a third light source for directing light at the third wavelength through the tissue or the subject, the third light source being either the first or second light sources adapted to emit light at more than one wavelength or a separate light source located adjacent the first and second light sources;

(e) providing at least one detector for detecting the portion of the light of the first, second and third wavelengths not absorbed by the tissue of the subject;

(f) measuring the absorbance of light at each of the three wavelengths at the systolic and diastolic phase of pulsatile blood flow;

(g) calculating the change in light absorbance between the systolic and diastolic phases for each of the first, second, and third wavelengths;

(h) calculating the difference between the changes in absorbances between the systolic and diastolic phases between the first and second wavelengths;

(i) determining a physical dimension of said tissue at both the systolic and diastolic phases of the subject'"'"'s pulsatile flow;

(j) calculating the change in the physical dimension of said tissue between the systolic and diastolic phases of the subject'"'"'s pulsatile flow;

(k) calculating a value by applying a formula employing three empirically derived regression constants and three variables, the first variable being the ratio of the difference between the changes in absorbances between the systolic and diastolic phases at the first two wavelengths as calculated in step (h) to the change in the physical dimension of said tissue between the systolic and diastolic phases as calculated in step (j), the second variable being the ratio of the change in light absorbance between the diastolic and systolic phases for the third wavelength as calculated in step (g) to the change in the physical dimension of said tissue as calculated in step (j), and the third variable being the reciprocal of the change in the physical dimension of said tissue as calculated in step (j);

(l) determining the concentration of said blood component by comparing the value calculated in step (k) to a reference.

25. The method of claim 24 wherein said blood component is glucose.

26. The method of claim 25 wherein said interfering substance is hemoglobin.

27. The method of claim 25 wherein said first wavelength is approximately 9020 nm.

28. The method of claim 25 wherein said second wavelength is approximately 8400 nm.

29. The method of claim 24 wherein said third wavelength is approximately 548 nm.

30. The method of claim 24 wherein at least one of said light sources is a heater coil.

31. The method of claim 30 wherein said light sources are the same heater coil and band pass filters are interposed between the heater coil and the tissue.

32. The method of claim 24 wherein at least one of said light sources is a light emitting diode, a laser or an incandescent lamp.

33. The method of claim 24 wherein the detector is a photodetector.

34. The method of claim 24 wherein the physical dimension of said tissue is the linear distance between the light sources and the detector.

35. The non-invasive method of claim 34 wherein the linear distance between the light sources and the detector is measured using a linear displacement transducer, a pair of opposing piezoelectric crystals or a magnetometer.

36. The method of claim 24 wherein the reference is a value calculated in accordance with step (k) for reference subjects with known concentrations of the blood component.

37. A non-invasive method for measuring the concentration of a blood component in a subject'"'"'s blood when an interfering substance absorbs at the optimal wavelength for detecting the concentration of the blood component, said method comprising:

(a) choosing a first wavelength of light at which the blood component absorbs light relatively strongly in comparison to all other substances expected to be present in the subject'"'"'s blood and the interfering substance also absorbs light to a substantial degree;

(b) choosing a second wavelength of light at which the interfering substance absorbs light to a substantial degree;

(c) providing a first light source for directing light at the first wavelength through tissue of the subject in which the light absorbance of arterial blood can be detected by measuring changes in absorbance during pulsatile flow of blood;

(d) providing a second light source for directing light at the second wavelength through the tissue of the subject, the second light source either being the first light source adapted to emit light at more than one wavelength or a separate light source located adjacent to the first light source;

(e) providing at least one detector for detecting the portion of the light of the first wavelength and the second wavelength not absorbed by the tissue of the subject;

(f) determining a physical dimension of said tissue at both the systolic and diastolic phases of the subject'"'"'s pulsatile flow;

(g) calculating the change in the physical dimension of said tissue between the systolic and diastolic phases of the subject'"'"'s pulsatile flow;

(h) measuring the absorbance of light for each of the first wavelength and the second wavelength at the systolic and diastolic phases of pulsatile blood flow;

(i) calculating the change in light absorbance between the systolic and diastolic phases for both the first wavelength and second wavelengths;

(j) calculating a ratio of the change in light absorbance as calculated in step (i) to the change in the physical dimension of said tissue and the detector as calculated in step (g) for each of the first and second wavelengths;

(k) calculating a value by applying a formula employing three empirically derived regression constants and three variables, the first variable being the ratio of the change in light absorbance at the first wavelength to the change in the physical dimension of the tissue between the systolic and diastolic phases as determined in step (j), the second variable being the ratio of the change in light absorbance at the second wavelength to the change in the physical dimension of said tissue between systolic and diastolic phases as determined in step (j) and the third variable being the reciprocal of the change in the physical dimension of said tissue between the systolic and diastolic phases as calculated in step (g); and

(l) determining the concentration of the blood component by comparing the value calculated in step (k) to a reference.

38. The method of claim 37 wherein said reference is a value calculated in accordance with step (k) for reference subjects with known concentrations of the blood component.

39. The method of claim 37 wherein said blood component is bilirubin.

40. The method of claim 39 wherein said interfering substance is hemoglobin.

41. The method of claim 39 wherein said first wavelength is approximately 420 nm.

42. The method of claim 39 wherein said second wavelength is approximately 548 nm.

43. The method of claim 37 wherein the physical dimension of said tissue is the linear distance between the light sources and the detector.

44. The method of claim 43 wherein the linear distance between the light sources and the detector is measured using a linear displacement transducer, a pair of opposing piezoelectric crystals or a magnetometer.

45. A device for the non-invasive measurement of the concentration of a blood component in a subject'"'"'s blood, said device comprising:

(a) at least one light transmission set comprising;

(i) at least one light source;

(ii) at least one detector for detecting the light emitted by the light source mounted apart from the light source such that the subject'"'"'s tissue is adapted to be interposed between the detector and light source, the light source mounted so as to transilluminate the tissue and the detector mounted so as to detect the light from said light source not absorbed by said tissue,

(b) a base adapted for holding a portion of the tissue of the subject through which pulsatile flow of arterial blood can be detected, said base including at least a portion of the light transmission set;

(c) means for measuring changes in a physical dimension of said tissue between the light source and the detector;

(d) means for transmitting data from the light detector;

(e) means for transmitting data from the means for measuring change in said physical dimension of said tissue; and

(f) means for receiving the transmitted data and for calculating the concentration of the blood component by calculating the ratio of change in light absorbance in the systolic and diastolic phase divided by the change in physical dimension of the tissue and comparing the ratio to a reference.

46. The device of claim 45 wherein said light source is a light-emitting diode, a laser, a heater coil or an incandescent lamp.

47. The device of claim 45 wherein the detector is a photodetector.

48. The device of claim 45 wherein the physical dimension of said tissue is the linear distance between the light source and the detector.

49. The device of claim 48 wherein said means for measuring changes in linear distance is a linear displacement transducer, a pair of opposing piezoelectric crystals or a magnetometer.

50. The device of claim 45 wherein the reference is a ratio of change in light absorbance in the systolic and diastolic phases divided by the change in the physical dimension of said tissue calculated for reference subjects with known concentrations of the blood component.